Furosemide

Product NDC
64980-563
11-digit product format
649800563
Labeler code
64980
Product ID
64980-563_458b3c62-666c-43f2-8feb-ee8e6cbe8931
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Furosemide
Dosage form
TABLET
Route
ORAL
Labeler
Rising Pharma Holdings, Inc.
Application
ANDA216629
Marketing category
ANDA
Marketing start
2022-11-05
Substance
FUROSEMIDE
Active strength
40 mg/1
Pharmacologic classes
Increased Diuresis at Loop of Henle [PE], Loop Diuretic [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A216629-001FUROSEMIDEFUROSEMIDE20MGTABLET / ORALAB2022-10-17
A216629-002FUROSEMIDEFUROSEMIDE40MGTABLET / ORALAB2022-10-17
A216629-003FUROSEMIDEFUROSEMIDE80MGTABLET / ORALABRS2022-10-17

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
A216629-001AB
A216629-002AB
A216629-003AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 75 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A216629-001FUROSEMIDE20MGTABLET / ORALAB2022-10-17011fe1cb6892…
2026-02-19 14:30 UTC2026-02A216629-002FUROSEMIDE40MGTABLET / ORALAB2022-10-17011fe1cb6892…
2026-02-19 14:30 UTC2026-02A216629-003FUROSEMIDE80MGTABLET / ORALABRS2022-10-17011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A216629-001FUROSEMIDE20MGTABLET / ORALAB2022-10-1731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A216629-002FUROSEMIDE40MGTABLET / ORALAB2022-10-1731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A216629-003FUROSEMIDE80MGTABLET / ORALABRS2022-10-1731067a03dcf5…
2025-08-23 18:47 UTC2025-08A216629-001FUROSEMIDE20MGTABLET / ORALAB2022-10-176a471c1ec25d…
2025-08-23 18:47 UTC2025-08A216629-002FUROSEMIDE40MGTABLET / ORALAB2022-10-176a471c1ec25d…
2025-08-23 18:47 UTC2025-08A216629-003FUROSEMIDE80MGTABLET / ORALAB2022-10-176a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A216629-001FUROSEMIDE20MGTABLET / ORALAB2022-10-17fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A216629-002FUROSEMIDE40MGTABLET / ORALAB2022-10-17fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A216629-003FUROSEMIDE80MGTABLET / ORALAB2022-10-17fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A216629-001FUROSEMIDE20MGTABLET / ORALAB2022-10-17b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A216629-002FUROSEMIDE40MGTABLET / ORALAB2022-10-17b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A216629-003FUROSEMIDE80MGTABLET / ORALAB2022-10-17b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A216629-001FUROSEMIDE20MGTABLET / ORALAB2022-10-1703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A216629-002FUROSEMIDE40MGTABLET / ORALAB2022-10-1703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A216629-003FUROSEMIDE80MGTABLET / ORALAB2022-10-1703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A216629-001FUROSEMIDE20MGTABLET / ORALAB2022-10-172680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A216629-002FUROSEMIDE40MGTABLET / ORALAB2022-10-172680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A216629-003FUROSEMIDE80MGTABLET / ORALAB2022-10-172680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A216629-001FUROSEMIDE20MGTABLET / ORALAB2022-10-175bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A216629-002FUROSEMIDE40MGTABLET / ORALAB2022-10-175bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A216629-003FUROSEMIDE80MGTABLET / ORALAB2022-10-175bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A216629-001FUROSEMIDE20MGTABLET / ORALAB2022-10-17d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A216629-002FUROSEMIDE40MGTABLET / ORALAB2022-10-17d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A216629-003FUROSEMIDE80MGTABLET / ORALAB2022-10-17d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A216629-001FUROSEMIDE20MGTABLET / ORALAB2022-10-17d06236e962d9…
2024-10-29 15:01 UTC2024-10A216629-002FUROSEMIDE40MGTABLET / ORALAB2022-10-17d06236e962d9…
2024-10-29 15:01 UTC2024-10A216629-003FUROSEMIDE80MGTABLET / ORALAB2022-10-17d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A216629-001FUROSEMIDE20MGTABLET / ORALAB2022-10-1779d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A216629-002FUROSEMIDE40MGTABLET / ORALAB2022-10-1779d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A216629-003FUROSEMIDE80MGTABLET / ORALAB2022-10-1779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A216629-001FUROSEMIDE20MGTABLET / ORALAB2022-10-17301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A216629-002FUROSEMIDE40MGTABLET / ORALAB2022-10-17301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A216629-003FUROSEMIDE80MGTABLET / ORALAB2022-10-17301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A216629-001FUROSEMIDE20MGTABLET / ORALAB2022-10-171e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A216629-002FUROSEMIDE40MGTABLET / ORALAB2022-10-171e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A216629-003FUROSEMIDE80MGTABLET / ORALAB2022-10-171e350fbaab3a…
2024-05-31 18:47 UTC2024-05A216629-001FUROSEMIDE20MGTABLET / ORALAB2022-10-178072bd15b7f6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 75 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A216629-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A216629-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A216629-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A216629-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A216629-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A216629-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A216629-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A216629-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A216629-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A216629-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A216629-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A216629-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A216629-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A216629-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A216629-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A216629-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A216629-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A216629-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A216629-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A216629-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A216629-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A216629-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A216629-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A216629-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A216629-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A216629-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A216629-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A216629-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A216629-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A216629-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A216629-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A216629-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A216629-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A216629-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A216629-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A216629-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A216629-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A216629-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A216629-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A216629-001AB18072bd15b7f6…

Additional Listing Data#

Finished product
Yes
Brand name base
Furosemide
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FUROSEMIDE40 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
7LXU5N7ZO5Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
197732Internal RxNorm lookup
310429Internal RxNorm lookup
313988Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
6101b9b4-f3ef-438e-a857-b4ea55ffc679Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d80d3aff-3a63-4d7b-a2be-fd9388b04330Product name920250806
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
9061e89f-9c86-4196-b34b-886fc1673cc4Product name120140821

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
64980-563-01Furosemide100 in 1 BOTTLETABLET1004
64980-563-10Furosemide1000 in 1 BOTTLETABLET10004

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
64980-563-01EA - Each64980-563a0556ca4-9966-4bf4-8062-1c3855d3055912022-11-07
64980-563-10EA - Each64980-5633e7fdd93-afac-446b-ab99-b946a6d09df812022-11-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64980-563FUROSEMIDE TABLET [RISING PHARMA HOLDINGS, INC.]3Current NDC, Legacy NDC, 2 package rows20230610_6101b9b4-f3ef-438e-a857-b4ea55ffc679.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 16 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
FurosemideFUROSEMIDESt. Mary's Medical Park Pharmacyfebeaf8c-0f4b-cc40-e053-6394a90a873e2026-06-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 216629
application number: ANDA216629
FurosemideFUROSEMIDERedpharm Drug37457273-38a1-f938-e063-6294a90a50ab2026-04-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 216629
application number: ANDA216629
FurosemideFUROSEMIDEREMEDYREPACK INC.dba00759-87b4-4ecf-998e-ba03ed3d2f1a2026-04-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 216629
application number: ANDA216629
FurosemideFUROSEMIDEPreferred Pharmaceuticals Inc.adda78ee-0cf5-4613-a748-5d6571afe3542026-01-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 216629
application number: ANDA216629
FurosemideFUROSEMIDEA-S Medication Solutions8f56d6f6-a5ea-4171-9e24-d2fdb11a65f82026-01-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 216629
application number: ANDA216629
FurosemideFUROSEMIDENorthwind Health Company, LLC13ba97a7-598a-76a4-e063-6294a90a45c52026-01-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 216629
application number: ANDA216629
FurosemideFUROSEMIDERedpharm Drug3745be12-ea1d-f450-e063-6294a90a148c2025-12-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 216629
application number: ANDA216629
FurosemideFUROSEMIDEA-S Medication Solutions54a33042-a163-4f93-96cc-fbd93030e0142025-12-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 216629
application number: ANDA216629
FurosemideFUROSEMIDEA-S Medication Solutions6864b3f6-c5ad-4588-ad04-5260258c6d8c2025-12-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 216629
application number: ANDA216629
FurosemideFUROSEMIDENuCare Pharmaceuticals, Inc.20eecc36-dfb7-0060-e063-6394a90a9d0b2025-10-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 216629
application number: ANDA216629
FurosemideFUROSEMIDEA-S Medication Solutions6194face-c26c-46ed-bde7-1e29bfeabd882025-10-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 216629
application number: ANDA216629
FurosemideFUROSEMIDEBryant Ranch Prepack53c3f50f-57c6-441b-afea-ec43d7943d1a2025-09-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 216629
application number: ANDA216629
FurosemideFUROSEMIDEPrefferred Pharmaceuticals Inc.ede9846b-b4c5-4be2-9188-fd65e66cd8932025-04-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 216629
application number: ANDA216629
FurosemideFUROSEMIDERising Pharma Holdings, Inc.6101b9b4-f3ef-438e-a857-b4ea55ffc6792025-02-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 216629
application number: ANDA216629
ndc (product): 64980-563
FurosemideFUROSEMIDENuCare Pharmaceuticals,Inc.0b3d986c-eecc-adbe-e063-6294a90a0fb22025-02-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 216629
application number: ANDA216629
FurosemideFUROSEMIDEBryant Ranch Prepack6c2ee3a4-afea-4e1f-84e6-def0221ad4372024-01-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 216629
application number: ANDA216629

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313988furosemide 40 MG Oral TabletPSN6c2ee3a4-afea-4e1f-84e6-def0221ad437100
313988furosemide 40 MG Oral TabletSCD6c2ee3a4-afea-4e1f-84e6-def0221ad437100
313988furosemide 40 MG Oral TabletPSN8f56d6f6-a5ea-4171-9e24-d2fdb11a65f85
313988furosemide 40 MG Oral TabletSCD8f56d6f6-a5ea-4171-9e24-d2fdb11a65f85
310429furosemide 20 MG Oral TabletPSN6101b9b4-f3ef-438e-a857-b4ea55ffc6794
313988furosemide 40 MG Oral TabletPSN6101b9b4-f3ef-438e-a857-b4ea55ffc6794
197732furosemide 80 MG Oral TabletPSN6101b9b4-f3ef-438e-a857-b4ea55ffc6794
310429furosemide 20 MG Oral TabletSCD6101b9b4-f3ef-438e-a857-b4ea55ffc6794
313988furosemide 40 MG Oral TabletSCD6101b9b4-f3ef-438e-a857-b4ea55ffc6794
197732furosemide 80 MG Oral TabletSCD6101b9b4-f3ef-438e-a857-b4ea55ffc6794
313988furosemide 40 MG Oral TabletPSN3745be12-ea1d-f450-e063-6294a90a148c3
313988furosemide 40 MG Oral TabletPSN6194face-c26c-46ed-bde7-1e29bfeabd883
313988furosemide 40 MG Oral TabletSCD3745be12-ea1d-f450-e063-6294a90a148c3
313988furosemide 40 MG Oral TabletSCD6194face-c26c-46ed-bde7-1e29bfeabd883
313988furosemide 40 MG Oral TabletPSNadda78ee-0cf5-4613-a748-5d6571afe3542
313988furosemide 40 MG Oral TabletPSN0b3d986c-eecc-adbe-e063-6294a90a0fb22
313988furosemide 40 MG Oral TabletPSNfebeaf8c-0f4b-cc40-e053-6394a90a873e2
313988furosemide 40 MG Oral TabletSCDfebeaf8c-0f4b-cc40-e053-6394a90a873e2
313988furosemide 40 MG Oral TabletSCDadda78ee-0cf5-4613-a748-5d6571afe3542
313988furosemide 40 MG Oral TabletSCD0b3d986c-eecc-adbe-e063-6294a90a0fb22
313988furosemide 40 MG Oral TabletPSN26a40a25-a858-a05b-e063-6394a90a791b1
313988furosemide 40 MG Oral TabletPSN00dbe76e-639f-0919-e063-6394a90a527a1
313988furosemide 40 MG Oral TabletSCD26a40a25-a858-a05b-e063-6394a90a791b1
313988furosemide 40 MG Oral TabletSCD00dbe76e-639f-0919-e063-6394a90a527a1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
64980-563-0164980056301100 TABLET in 1 BOTTLE (64980-563-01) 100 tablet2022-11-050000-00-00NoNoCurrent
64980-563-10649800563101000 TABLET in 1 BOTTLE (64980-563-10) 1000 tablet2022-11-050000-00-00NoNoCurrent